NIM CONTACT® 8229508Recalls & reported problems

Medtronic Xomed, Inc. · EMG TUBE 8229508 NIM CONT 8MM ROHS · Class 2

All models of NIM Contact (6)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169789579), received between Jan 25, 2023 and Mar 14, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Inappropriate Audible Prompt/Feedback” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

Apr 29, 2022Open, Classified
The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.
Z-1519-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Device problems

Inappropriate Audible Prompt/Feedback1
Incorrect, Inadequate or Imprecise Result or Readings1
Use of Device Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionMar 14, 2024Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback
IT WAS REPORTED THAT INTRA OP DEVICE HAS UNEXPLAINED ACTIVITY ON CHANNEL 2. THERE WAS POSSIBLE SPONTANEOUS EMG AS IT HAD BIPHASIC WAVELENGTHS. TROUBLESHOOTING WAS DONE BY USER THAT USER LET 1-2ML OF AIR OUT OF THE CUFF AND SWAPPED RED AND BLUE ELECTRODES WITH EACH OTHER TO ELIMINATE A PI BOX ISSUE. THE ACTIVITY FOLLOWED THE CHANNEL WHEN SWAPPED RED AND BLUE ON PI BOX. THE ACTIVITY WENT AWAY ABOUT 5 MINUTES AFTER SWITCHING THE RED AND BLUE ELECTRODES WITH EACH OTHER ON PI BOX. USER WAS ABLE TO STIMULATE AND USE THE NIM VITAL FOR MONITORING THROUGHOUT THE CASE. AND ELECTRODE CHECK WAS PERFORMED. THERE WAS NO DELAY IN CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18905376 ↗
MalfunctionJan 25, 2023Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT PATIENT WAS INTUBATED WITH ENDOTRACHEAL TUBE,WHEN THE TUBE WAS ATTACHED TO THE NERVE INTEGRITY MONITOR MACHINE, IT DID NOT WORK. THE ENDOTRACHEAL TUBE WAS FUNCTIONING PROPERLY, BUT THE NIM CAPABILITY DID NOT FUNCTION. THE TUBE WAS REPLACED WITH ANOTHER IDENTICAL DEVICE, AND THE SECOND ONE WORKED PROPERLY WITH THE NERVE INTEGRITY MONITOR MACHINE. NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16242643 ↗

Device details

UDI-DI	`00643169789579`
Brand	NIM CONTACT®
Model	8229508
Company	Medtronic Xomed, Inc.
Product code	ETN · STIMULATOR, NERVE
Class	Class 2
FDA submission	K050162
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Jun 19, 2020

Device type (GMDN): Basic endotracheal tube, single-use

A hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated; it does not include an antimicrobial agent(s). The device may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) be radiopaque; and 4) have a built-in pilot balloon for cuff pressure monitoring. It is available in various diameters and lengths for adult and paediatric patients. This is a single-use device.

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All STIMULATOR, NERVE devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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